Website link to clinical trials databases set up

Links to major websites that list registrations of forthcoming clinical trials are being made available here on the website of the Association of the British Pharmaceutical Industry (ABPI) from today, when the global agreement on making such information publicly available comes into effect.

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​With hyperlinks to six different websites available, details of more than 4,000 clinical trials, which are either completed, taking place or planned, can be accessed. Of these, some 1,139 trials are still ongoing and may be recruiting patients to take part.

"For some time, the UK-based industry has been firmly committed to the principle of enabling public access to information about clinical trials, and the establishment of these links on our website is a further help to those who want information about such research," said Dr Richard Barker, Director General of the ABPI.

"This is merely the next step in the process - the international industry is also in the process of establishing a portal to all clinical trial websites worldwide - but it clearly demonstrates our very real desire to make this information readily available to those who want it."

Proposals to establish a worldwide register of clinical trials on new prescription-only medicines were announced at the beginning of the year. There are two elements to the proposals, which were drawn up by the world's major industry trade associations with the involvement of the ABPI and agreed by major companies:

Results of all industry-sponsored clinical trials on a medicine that has been approved for marketing, and which evaluate its safety and benefit, will be publicly disclosed via free, publicly accessible databases, regardless of outcome. This came into effect in January this year, with a maximum period of one year before publication.

Details of all clinical trials being performed to determine a medicine's therapeutic benefit will be publicly registered at initiation so that patients and clinicians will have information on how to enrol. Forthcoming trials have to be listed from today with those in various stages of progress by September 13.

The industry has committed itself to making available information on all clinical trials, other than exploratory trials - and even those results will be published if they have significant medical importance.

The results will be published in a standard, non-promotional summary that will include a description of trial design and methodology, results of primary and secondary outcome measures described in the protocol, and safety results. However, if the results are also published in a peer-reviewed medical journal, the database will alternatively include a link to the relevant article and, in some cases, the summary as well.

The results should normally be published within one year after the medicine is approved or, for post-approval trials, within one year of them being completed.

Rather than placing all information on a single website, the industry will ensure that all such sites are linked, since several companies have already set up their own arrangements. An internet portal will be established before the end of the year by the International Federation of Pharmaceutical Manufacturers' Associations (IFPMA), and the World Health Organisation (WHO) is also committed to establishing a portal.

The ABPI listing of major websites is available below. It includes hyperlinks to the US-based clinical trials register, the ABPI's own UK-centred website, and the listings being provided by five major, individual companies.

The initiative was drawn up following discussions between the European Federation of Pharmaceutical Industries and Associations (EFPIA); the IFPMA; the Japanese Pharmaceutical Manufacturers' Association (JPMA); and the Pharmaceutical Research and Manufacturers of America (PhRMA).

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